Phase 2 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had a confirmed asthma diagnosis for at least 6 months.
• A parent or legal guardian must sign a consent form on behalf of the child, and the child may also need to give their agreement to take part, depending on local rules.
• The child must be taking a stable, low-to-medium dose of an inhaled corticosteroid (a preventer inhaler) plus one other asthma controller medication, with no dose changes for at least 4 weeks before the trial's run-in period.
• Lung function test results (a measure called FEV1) must fall within a specific range — between 60% and 90% of what is considered normal for the child's age and size — at the start of and before full entry into the trial (confirm with trial site if unsure).
• Lung function must show a meaningful improvement (at least 12%) after using a reliever inhaler during an early trial visit; if this is not shown the first time, there may be limited opportunities to retest.
• The child must be able to use two specific types of inhaler devices correctly, and must be able to complete breathing tests before the trial formally begins.
• A parent or legal guardian must be willing and able to attend all clinic visits with the child and help complete an electronic diary throughout the trial.
• A parent or legal guardian must be willing and able to help the child follow all study procedures, including taking study medications correctly and keeping the diary up to date.
• Female participants who could potentially become pregnant must agree to use effective contraception during the study if they become sexually active, and this must be reviewed at least every 3 months.

Who may not be able to join:

• Children who have taken steroid tablets or injections (systemic corticosteroids) for any reason in the 3 months before the run-in period.
• Children who are currently taking only a low-to-medium dose inhaled corticosteroid on its own, with no other controller medication.
• Children who have needed 6 or more puffs of reliever medication per day on more than 2 days in a row, during either the 4 weeks before first screening or the 4 weeks before the run-in visit.
• Children who have had a serious asthma attack in the 3 months before screening that required steroid tablets or injections, a hospital stay, or an emergency room visit, or who have had more than 3 separate asthma attacks in the 12 months before screening.
• Children who have been diagnosed with narrow-angle glaucoma, bladder problems, or any other condition where a type of medication called an anticholinergic is not considered safe to use.
• Children with a history of a heart rhythm condition called long QT syndrome, or whose heart rhythm measurements (taken at two separate points early in the trial) are outside the accepted range.
• Children who have an active infection of the respiratory tract, sinuses, or middle ear — including COVID-19 or tuberculosis — that has not fully cleared within 6 weeks of the first screening visit.
• Children with Type 1 diabetes, or Type 2 diabetes that is not well controlled.
• Children who are already sexually active at the time of screening.
• Children whose haemoglobin (a measure of red blood cells) levels are outside the normal range at the run-in visit.
• Female participants who could potentially become pregnant and do not agree to abstinence or, if they become sexually active during the trial, do not agree to use contraception as outlined in the trial requirements.

Important: Always verify eligibility with the trial site directly before applying.